search
Back to results

Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic Colorectal Cancer

Primary Purpose

Gene Mutation-Related Cancer, Traditional Chinese Medicine

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Traditional Chinese Medicine
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gene Mutation-Related Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A clear pathological diagnosis is a patient with colorectal cancer;
  2. Have complete TNM staging information;
  3. There is a clear diagnosis of the location and time of metastasis;
  4. Age ≥18 years old, ≤80 years old, male or female;
  5. There is a clear time for the first treatment with Chinese medicine;
  6. Patients who can receive long-term follow-up. -

Exclusion Criteria:

  1. Patients with colorectal cancer diagnosed pathologically as adenosquamous carcinoma, squamous cell carcinoma, carcinoid, small cell carcinoma, malignant lymphoma, etc.;
  2. Patients with double cancer, multiple or metastatic colorectal cancer;
  3. Combined with severe acute and chronic diseases that may affect treatment and prognosis, such as myocardial infarction, stroke, severe renal insufficiency and mental illness;-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TCM Syndrome Types

    Arm Description

    Traditional Chinese Medicine

    Outcomes

    Primary Outcome Measures

    Overall Survival
    OS
    Progression Free Survival
    PFS

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2020
    Last Updated
    December 8, 2020
    Sponsor
    Shanghai University of Traditional Chinese Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04661046
    Brief Title
    Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic Colorectal Cancer
    Official Title
    Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 30, 2020 (Anticipated)
    Primary Completion Date
    August 31, 2022 (Anticipated)
    Study Completion Date
    August 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai University of Traditional Chinese Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To explore the correlation between gene mutations of metastatic colorectal cancer and TCM syndrome types based on Second-generation sequencing technology.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gene Mutation-Related Cancer, Traditional Chinese Medicine

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TCM Syndrome Types
    Arm Type
    Experimental
    Arm Description
    Traditional Chinese Medicine
    Intervention Type
    Drug
    Intervention Name(s)
    Traditional Chinese Medicine
    Other Intervention Name(s)
    TCM
    Intervention Description
    Chinese medicine prescription
    Primary Outcome Measure Information:
    Title
    Overall Survival
    Description
    OS
    Time Frame
    2 years
    Title
    Progression Free Survival
    Description
    PFS
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A clear pathological diagnosis is a patient with colorectal cancer; Have complete TNM staging information; There is a clear diagnosis of the location and time of metastasis; Age ≥18 years old, ≤80 years old, male or female; There is a clear time for the first treatment with Chinese medicine; Patients who can receive long-term follow-up. - Exclusion Criteria: Patients with colorectal cancer diagnosed pathologically as adenosquamous carcinoma, squamous cell carcinoma, carcinoid, small cell carcinoma, malignant lymphoma, etc.; Patients with double cancer, multiple or metastatic colorectal cancer; Combined with severe acute and chronic diseases that may affect treatment and prognosis, such as myocardial infarction, stroke, severe renal insufficiency and mental illness;-

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic Colorectal Cancer

    We'll reach out to this number within 24 hrs